Report on the Canada Vigilance Database

April 15, 2015 By Vaccine Choice Canada

There is an understanding and an expectation that Health Canada and the Public Health Agency of Canada are actively monitoring adverse reactions to vaccinations, and that citizens can easily access this information in their effort to make an informed medical decision.

Ms. Anna Maria Tremonti, host of CBC’s The Current, responded recently to a parent’s concern about access to vaccine adverse reaction data with the following retort:

“Adverse effects on vaccinations are actually one of the most tracked things we have and they are available through the public health agency of Canada. You don’t know that?” “It’s right there.” (February 9, 2015, Transcript from The Current)

Unfortunately vaccine adverse reaction data is not “right there”.

Originally Vaccine Choice Canada set out to compare the Canadian vaccine adverse events reporting system with the U.S. Vaccine Adverse Events Reporting System (VAERS), which became active in 1990 following the National Childhood Vaccine Injury Act in 1986. Our goal was to analyze and compare the quality of data available in Canada and in the U.S. as well as compare ease of public access to vaccine associated reaction and injury reports submitted by medical personnel, vaccine manufacturers and the public in both countries. Unfortunately, this proved impossible.

Our investigation found that while vaccine adverse events data in the U.S. are readily accessible through a user friendly Med Alerts search engine, Canada operates a dual reporting system that is confusing, lacks transparency and is mostly inaccessible to the public.

Two Databases

From 1965–1987 physicians, pharmacists, public health nurses, hospitals, manufacturers and consumers reported adverse reactions to Health Canada for inclusion in the Canada Vigilance (CV) on-line database. These reports included reactions to vaccinations as well as all other drug products.

In 1988 the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) was established to specifically monitor adverse reactions to vaccinations. While this initiative increased the potential and ease for Health Canada (and later the Public Health Agency of Canada who inherited the CAEFISS database) to track vaccine reactions, it also represented a major setback in the public’s ability to access this data. The only access to CAEFISS data is through a formal access to information request, or from reports released periodically at the discretion of the government.

The vast majority of vaccine-associated adverse events reports are routed to the CAEFISS database where they remain inaccessible to public scrutiny.

As an example of what is hidden and what is revealed, the two, full public reports on CAEFISS confirm that from 1992 to 2012 the CAEFISS database recorded 87,911 vaccine adverse reaction reports. Compare this to the publicly accessible Canada Vigilance database which recorded 551 reports or less than 1% of all adverse reaction reports on CAEFISS during those same years.

Whatever the intent of the database reorganizations, the result is the Canadian public has little access to reports on adverse reactions following vaccinations.

93% of the data on the Canada Vigilance database is from the 22 pre-reorganization years (1965–1987) when everyone reported adverse reactions to this database. Only 6.5% of the data is from the 26 post-reorganization years. This affords the public little basis for making informed medical decisions on current immunizations.

The need for change

To whose advantage is this dysfunctional system of reporting and tracking? Certainly it is not in the public interest.

It is the firm belief of Vaccine Choice Canada that all vaccine adverse reaction data should be incorporated in one (or both) databases and that the public must have full access to that data.